Job Summary (Primary function)
The Director to Sr. Director, Digital Quality Management Systems (QMS) programs leads the digitalization of the Quality Management System. The person in this role owns the electronic enterprise Quality applications across the GxPs, ensuring their evolution to best serve the patients and business needs. This role is accountable for their continuous compliance with regulations.
Essential Functions of the Job (Key responsibilities)
- Develop and oversee the Digital Quality Management System governance model and roadmap that supports pre-clinical, clinical, manufacturing, distribution and Pharmacovigilance activities. Ensure alignment with the business needs and Quality Plan/Strategy
- Act as System owner of all digital GxP enterprise Quality applications
- Ensure the Digital QMS is maintained in accordance with current regulatory standards and meets corporate quality and business objectives
- Leads e-systems developments and enhancements projects in collaboration with the network of Quality process owners and IT
- Leverage Artificial Intelligence capabilities to enhance our digital QMS
- Develop and maintain digital Quality applications system administration processes, including business Continuity planning
- Assure Inspection readiness of digital Quality applications and be the Subject Matter Expert during Health Authorities Inspections on enterprise Quality applications
- Support the identification of digital solutions addressing Quality business needs
- Act as QA lead for cross functional GxP digital applications projects
- Manage the business relationship with the suppliers of digital quality applications
- Promote a strong Quality culture to ensure Incyte digital applications implementation and usage is fit for intended use and ensures highest level of data integrity and compliance
- Support the Global Quality leadership team in driving key Quality culture initiatives
- Responsible for developing and continuously improving core GxP and Quality training program, including strategy and delivery methods, fostering Incyte Culture of Quality
- Develop new and innovative approaches to GxP and Quality Trainings
- Collaborate with other GxP operational teams to develop a common framework for GxP trainings
- Collaborate closely with IT, Quality and Operations teams
- Conduct Corporate Quality audits
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Advanced degree in life sciences, quality, or related field required
- Minimum 10 years in Quality Assurance in a Pharmaceutical / Medical Device Industry in an international environment
- In-depth operational experience in one area of the GxP allowing solid understanding of Business needs in terms of digital quality applications
- Excellent knowledge of US, EU, ICH GxP regulations
- Experience in Managing and operating digital Quality applications
- Strong leadership, project management, and relationship building skills
- Ability to communicate complex information effectively across functions
- Certified quality auditor
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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